TNS for Major Depressive Disorder: a Phase II Randomized Controlled Trial

Phase 1

• Conditions: Depressive Symptoms
• Interventions: Device: Trigeminal Nerve Stimulation (TNS)

• Registration Number: NCT02105376
• Lead Sponsor: Santa Casa Medical School

Brief Summary

This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as primary objective to evaluate the effect of the Trigeminal Nerve Stimulation (TNS) on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in patients with moderate / severe depressive episode.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-07
• Study Start: 2014-05
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-03
• Last Update Posted: 2015-05-05
• Primary Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. patients between 18 and 69 years
2. patients with a diagnosis of depression according to the SCID
3. score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode)
4. agreement to participate in the study as recommended in the IC.

Exclusion Criteria

1. patients with psychiatric indication for hospitalization
2. patients with psychiatric comorbidity
3. patients with a diagnosis of personality disorder
4. presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trigeminal Nerve Stimulation (TNS)	Trigeminal Nerve Stimulation (TNS)	TNS active group TNS will be applied by the external simulator EMS400. The stimulation will be conducted at a frequency of 120 Hz with pulse duration of 200 microseconds. The current intensity will be individually established and should be equivalent to a slight feeling of not painful paresthesia (approximately 0.5-2mA). The stimulus generates a pulse and asymmetric biphasic waveform. Electrodes (25cm2) will be placed on the forehead just above the supraorbital foramen bilaterally.

Primary Outcome Measures

Name	Time	Method
Hamilton Depressive Rating Scale version 17 items (HDRS-17)	Change from baseline in depressive symptoms at 2 weeks	This clinical trial has as primary objective to evaluate the effect of the Trigeminal Nerve Stimulation (TNS) on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in patients with moderate / severe depressive episode.

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MOCA)	Change from baseline in cognitive functioning at 2 weeks	We also use the questionnaire Montreal Cognitive Assessment (MOCA) for assessment of cognitive function, considering the level of consciousness and global functioning in order to compare your score with estimates made by other instruments. It will also serve to assess possible cognitive damage and whether there are improvements in some specific cognitive functions with treatment

Trial Locations

Locations (1)

Centro de Atencao Integrada à Saúde Mental; 🇧🇷 Sao Paulo, SP, Brazil